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Marketed products, regulatory approvals and HTA decisions

Understand regulatory approval processes and health technology assessment (HTA) decisioning to identify opportunities, mitigate risk and optimize drug development and commercialization strategies.

A VISFO "intelligence board" showing various components of the “Marketed products" offering in desktop view. Included are visualizations of a "Competitive landscape comparison", an "Efficacy, safety and market share" analysis and a "Market entry and development milestones". A mobile screen shows a "Competitive landscape comparison" visualization as well as the available filters.

Definition

Criteria

Power your decision-making

with bespoke and intuitive intelligence boards

VISFO combines cutting-edge technology and deep subject matter expertise to de-silo data and enable confident decision-making. With all outputs housed in an agile, always-on delivery portal, you can quickly:

Visualize

Identify

  • Regulatory guidelines, policies and procedures across markets
  • Approval histories for marketed products, within and across indications
  • Different HTA bodies and their processes
  • Patterns in HTA outcomes and recommendations
A VISFO "intelligence board" showing various components of the “Marketed products" offering in desktop view. Included are visualizations of a "Competitive landscape comparison", an "Efficacy, safety and market share" analysis and a "Market entry and development milestones". A mobile screen shows a "Competitive landscape comparison" visualization as well as the available filters.

Analyze

  • Changes in regulatory guidelines, policies and procedures that may impact drug development and approval processes
  • Emerging regulatory frameworks, such as those related to personalized medicine or real-world evidence
  • Drug approval histories for marketed products within specific indications to identify potential market gaps and prioritize drug development efforts based on likelihood of successful market entry
  • The approval history of a single product across multiple indications to forecast potential indication updates based on historical trends and emerging therapeutic needs
  • HTA decisions for marketed products, including positive and negative outcomes, and the reasoning behind these to understand evidence requirements and other factors that contribute to favorable HTA decisions 

Use cases

Align your evidence and value messages with the specific requirements and preferences of HTA agencies and payers in each target market

Anticipate and address potential market access hurdles

Use competitor benchmarking to improve product positioning and payer appeal, increasing the likelihood of favorable reimbursement decisions

Design trial endpoints that maximize the chance of meeting expected regulatory and HTA requirements

Design trials that satisfy multiple regulatory bodies on the first submission

Facilitate strategic prioritization of your development portfolio based on regulatory and HTA forecasting

Develop external communication strategies that align with HTA and payer requirements

Craft scientifically robust and strategically aligned communication materials

Design and implement studies that effectively meet post-market requirements

Delivered through Helix

Modular knowledge base

  • Interactive data visualizations for easy self-serve analysis and insight surfacing

  • Comprehensive opinion leader profiles for effective interaction planning and engagement

  • Multiple data export options for rapid insight sharing across your business

  • Customizable, modular knowledge bases with no user limits

A VISFO "Key Opinion Leader (KOL) intelligence board" displayed on both a desktop and mobile screen. The board includes an interactive KOL map, as well as the results of a KOL influence analysis."